Study of Enteric-Coated Mycophenolate Sodium (EC-MPS) Plus Reduced-dose Cyclosporine Microemulsion (CsA-ME) Compared to EC-MPS Plus Standard Dose CsA-ME in Eldery de Novo Renal Transplant Recipients Treated With Basiliximab and Short-term Steroids
Phase 3
Completed
- Conditions
- Denovo Renal Transplantation
- Interventions
- Registration Number
- NCT00239031
- Lead Sponsor
- Novartis
- Brief Summary
All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug.
The aim of this study is to compare the renal function, 6 months after transplant, in de novo old-age renal transplant recipients treated with EC-MPS plus reduced dose CsA-ME or with EC-MPS plus standard dose CsA-ME, both in combination with basiliximab and short-term oral steroids.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 117
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Enteric-Coated Mycophenolate Sodium -
- Primary Outcome Measures
Name Time Method The 6-month study values of creatinine clearance, as calculated according to Cockcroft and Gault, summarized and compared between treatment groups.
- Secondary Outcome Measures
Name Time Method Incidence of treatment failure (biopsy-proven and/or treated acute rejection, graft loss, death or loss to follow-up at 6 and 12 months; Incidence of biopsy proven acute rejection at Month 6 and 12 Incidence of graft loss at Month 6 and 12 Rate of delayed graft function (DGF) and the time to adequate renal function (serum creatinine < 2,5 mg/dL); Pharmacokinetics of MPA and MPAG at Day 15, Month 3 and Month 6